FDA extends Inbrija NDA review period
The US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Parkinson’s disease candidate Inbrija (levodopa inhalation powder) from October 5, 2018 to January 5, 2019.
This marks another setback for Acorda Therapeutics (Nasdaq: ACOR), the drug’s developer, which in August 2017 received a Refusal to File (RTF) letter regarding the drug from the FDA. Last November, the company also gave up on its tozadenant for Parkinson's disease, days after the company’s Phase III trial program was effectively halted due to worrying safety data.
The latest news also comes just days after the company lost its appeal of a court decision invalidating four patents protecting its multiple sclerosis treatment Ampyra (dalfampridine).
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze